FDA 510(k) Application Details - K091268

Device Classification Name	Catheter, Oximeter, Fiberoptic   More FDA Info for this Device
510(K) Number	K091268
Device Name	Catheter, Oximeter, Fiberoptic
Applicant	HOSPIRA, INC. 275 NORTH FIELD DR. LAKE FOREST, IL 60045 US Other 510(k) Applications for this Company
Contact	DANIELA WEKSLER Other 510(k) Applications for this Contact
Regulation Number	870.1230   More FDA Info for this Regulation Number
Classification Product Code	DQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2009
Decision Date	09/18/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review